Validation Engineer 1
Validation Engineer 1
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1 Vacancy
Job Description
This positions primary role is to work closely with the internal IT teams and cross functional departments (Business & PQ-CSV) to support computer system validation activities related to projects and change requests.
Top Skills:
Good understanding of CSV CSA FDA regulations (21 CFR Part 11 & 820) GAMP5 & GxP regulations.
Essential Job Duties (Specific responsibilities and tasks an individual would be expected to perform in the role. Additional job duties may be determined by functional people manager)
Responsible for oversight of all GxP-regulated computerized systems at all applicable points of the computerized system lifecycle ensuring compliance with regulatory requirements Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.
Provide oversight of validation activities lead the development and approval of validation documentation and risk assessments work with project teams to determine which elements should be validated and conduct impact assessment of proposed changes to computerized systems.
Perform and/or direct GxP computerized system validation projects in compliance with 21 CFR 820 21 CFR Part 11 Annex 11 and Data Integrity.
Ensure that GxP systems meet intended uses and comply with applicable regulations current industry practices and *** policies and procedures.
Development and approval of Validation Plans IQ OQ Protocols Trace Matrices Risk Assessments and Validation Summary Reports.
Establish validation standards develop testing protocols document test results and maintain records for later analysis.
Documentation and remediation of deviations resulting from validations/qualifications.
Provide assistance and guidance in training co-workers on validation protocols and operating procedures.
Author/Update assigned Operating Procedures (SOPs & DOPs) Policies validation templates to ensure compliance with Company policies and federal regulations.
Support regulatory agency inspections/audits as required.
Must be familiar with cGMPs and current industry guidelines.
Interfaces between various internal and external functional areas to assure successful integration and completion of validation activities in overall project schedules.
Maintains awareness of regulatory requirements.
Understanding of FDAs new guidance of CSA risk based approach validation
Required Skills and Experience (Specific skills knowledge and experience that an individual must possess in order to successfully perform in job)
Knowledge of fundamental cGMP concepts and FDA/EMA regulations QSR 21 CFR Part 820 21 CFR Part 11 and ISO 9001 Standards.
Strong knowledge of FDA Regulated manufacturing processes process validation computer and equipment validation and GMPs.
Hands-on experience in EDMS (Electronic Document Management system) & Test Management tools.
Understanding of FDAs recent guidance on transition of CSV to CSA.
Ability to develop clear concise and timely oral and written reports. Excellent written and oral communication skills.
Ability to work on complex projects with general direction and minimal guidance.
Ability to handle multiple projects and meet deadlines.
Ability to manage priorities and workflow. Versatility flexibility and a willingness to work within constantly changing priorities with enthusiasm.
Required Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)
Bachelors degree (B.S.) in a related field or equivalent.
8 years hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry (Medical Device/Pharma/Life Sciences) with a focus on GxP systems.
Preferred Skills and Experience (As applicable - Specific skills knowledge and experience that are not required to perform the job but are desirable to have)
Hands-on experience with Microsoft Word Excel PowerPoint & Visio.
Hands-on experience with EDMS (Electronic Document Management system) & Test Management tools.
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Employment Type
Full-time
